Viiv Healthcare's marketing application for fostemsavir started off being fast-tracked through the review process at the European Medicines Agency in January but is now being reviewed under standard timelines. The product is being developed for the treatment of adults with multidrug resistant HIV-1 infection.
The EU marketing authorization application (MAA) for fostemsavir, ViiV Healthcare’s potential first-in-class attachment inhibitor for the treatment of HIV-1 infection, has lost its accelerated assessment status and is now being reviewed under standard review timelines at the European Medicines Agency.
Fostemsavir, for the treatment of HIV in adults with few treatment options available, first appeared on the EMA’s list of...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
